The U.S. Food and Drug Administration is turning to an Akron-area partnership for its expert knowledge about medical devices made from polymer materials.
The federal agency on Thursday entered a memorandum of understanding with the Austen BioInnovation Institute in Akron for scientific collaborations and educational initiatives.
Under the agreement, the BioInnovation Institute will provide the Food and Drug Administration (FDA) with help characterizing these novel materials and developing review protocols for safety, said Dr. Frank Douglas, the institute’s president and chief executive.
The deal marks the FDA’s first collaboration centering around medical devices using polymers. In recent years, the Austen BioInnovation Institute in Akron (ABIA) and its Akron partners have been developing a national reputation within the field.
“This is really big,” Douglas said. “I think what they saw was a real environment with technical capabilities, the sophistication to understand the regulatory issues with developing devices. We are recognized as leaders. We are able, not only in Akron, but on a national basis to bring together leaders.”
The deal with the FDA should help attract medical device companies and startup businesses to the region that want access to the expertise the area can offer, Douglas said.
“If the FDA sees what we have here as being worthy of a collaboration, that will signal to businesses that the expertise is indeed here,” he said. “We can pull together here in Akron as well as nationally the expertise to address the problems that they have.”
The BioInnovation Institute brings together the polymer expertise of the University of Akron with the clinical and research expertise at the Northeast Ohio Medical University and Akron’s three hospital systems, Akron General, Akron Children’s and Summa.
The Akron-based institute will get paid by the FDA per project as the collaboration develops, Douglas said. FDA researchers also will come to Akron in the future to work with area scientists.
“The FDA can better fulfill its commitment to protect and promote public health if it draws upon the intellectual resources, laboratory capacity and research capabilities that reside in academic centers such as ABIA,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a news release. “Our partnership with ABIA will advance regulatory science by augmenting our capability to examine and better understand engineered tissues, polymers and coatings and to detect nanoparticle surface defects.”
As devices such as pacemakers are being developed with new biomaterials that are thinner than ever before, for example, it becomes increasingly important to make sure microscopic cracks don’t occur, Douglas said.
Douglas also cited fears years ago about breast implants causing immunological illnesses as an example of the need for better understanding about how the human body responds to new biomaterials.
“We are not responsible for making any decisions about regulatory approval,” Douglas said. “But for the technical assessment of materials, we’ll collaborate with them and exchange information on a technical basis.”
The BioInnovation Institute will help the FDA define the properties of new biomedical materials and better detect defects, said Matthew Becker, associate professor of polymer science at the University of Akron.
Polymer opportunities
Becker also serves as co-director of the Akron Functional Materials Center, a joint initiative between the BioInnovation Institute and the university to promote rapid prototyping and advanced development of polymers.
Products could include everything from ocular lenses to stent coatings to implanted polymer structures on which tissue is regrown, he said.
“It’s something where there’s a lot of opportunity for training, for education, for partnered research — all designed to really advance the state of the art in polymer in the United States,” he said.
Cheryl Powell can be reached at 330-996-3902 or chpowell@thebeaconjournal.com. Follow Powell on Twitter at twitter.com/abjcherylpowell.
